Strategies to establish GMP manufacturing platform for autologous cell therapies transiting from research into clinical phase

Strategies to establish GMP manufacturing platform for autologous cell therapies transiting from research into clinical phase

Master’s

12 pages

Discipline: Medicine and Health

Type of service:                Power Point Presentation with Speaker Notes

Paper format:    Harvard

5 sources

The topic of the presentation is:

“Strategies to establish GMP manufacturing platform for autologous cell therapies transiting from research into clinical phase”

Assignment Instructions:

Fueled by a recent resurgence in public financing and compelling clinical data for indications as diverse as acute macular degeneration and pancreatic cancer, a growing number of cell therapies are driving toward pivotal clinical studies and commercialization. Although regulatory precedents have been set for various autologous and allogeneic products in the United States, Asia, and the European

Union, regulatory guidance continues to evolve for a widening array of cell products.

Autologous cell and gene therapy is advancing rapidly and revolutionizing patient care. However, to truly turn these remarkable therapies into mass-market products, a long road still lies ahead in order to realise and fully develop commercially scalable solutions.

Challenges which might be considered routine for conventional biologics, e.g. – manufacturing processes, quality and safety, analytical characterization, etc, represent unique and complex when dealing with these cell therapies (especially for autologous treatments), and this unique barriers would need to be addressed.

Provide a compelling presentation on the strategies to establish GMP manufacturing platform for autologous cell therapies as they transition from research into clinical phase, which covers the following areas:

• Strategies to establish key GMP systems for cell therapy products;
• Potential challenges in establishing these systems for autologous cell therapy products;
• Potential solutions.

It is essential that you properly attribute all quotes, ideas, models, frameworks etc. that you include in your discussion and analysis. This includes any material that you may download from internet sources. Full references must be given for all sources using only the Harvard Referencing Convention. Include at least 5 references.